BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2901561 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-00300
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-30 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    TWO TO THREE MONTHS AFTER IMPLANT, IT WAS REPORTED THAT THE PATIENT NEVER HAD COUPLING WHILE RECHARGING. THE INS WAS A BUTTOCK IMPLANT AND FELT TILTED IN THE POCKET, AND IT WAS NOTED THAT THE PATIENT HAD LOST WEIGHT RECENTLY. IT WAS LATER REPORTED THAT THE PATIENT HAD THE NEUROSTIMULATOR REPOSITIONED TO A BACK LOCATION BECAUSE OF WEIGHT LOSS, THOUGH THE TIME OF THE REVISION WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9049 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention